|- candidate number||9248|
|- NTR Number||NTR2815|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-mrt-2011|
|- Secondary IDs||1150.0002 ZonMw|
|- Public Title||Palliative care in general practice.|
|- Scientific Title||Identification of and proactive palliative care for patients in general practice.|
|- hypothesis||According to the WHO, patients who can benefit from palliative care should be identified earlier to enable proactive palliative care. Up to now this hardly has been addressed in scientific literature. Therefore, the aim of our study is to determine if training GPs in how to identify palliative patients in an early phase of their disease trajectory and how to structure palliative care proactively, can improve different aspects of the quality of the remaining life of patients with severe chronic diseases such as COPD, CHF and cancer. |
|- Healt Condition(s) or Problem(s) studied||Palliative care , General practitioner, Randomized controlled trial, Movement coordination, Proactive care, Identification of patients|
|- Inclusion criteria||GPs in the region of two comprehensive cancer centers in the South-East of the Netherlands (IKO en IKZ).|
GPs will be stratified for degree of urbanization and working hours of the GP (part-time or full-time) and will be randomized by an independent statistician into the intervention or the control group. GPs working together in the same practice will be placed in the same group so that contamination is minimized.
|- Exclusion criteria||GPs will be excluded if they are consultant in palliative care or if they are locum.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2009|
|- planned closingdate||30-apr-2011|
|- Target number of participants||100|
|- Interventions||The intervention for the GPs in the experimental condition consists of three consecutive parts:|
1. A five hours training in early identification of the palliative population and proactive care planning. The early identification is based on two tools, developed in an earlier stage of the project. These are a card with indicators to identify and recognize patient as being in a stage that palliative care should be considered and another card which supports GPs in:
A. Checking in a structured way actual problems encountered by the patient for each domain at the moment of identification;
B. Thinking explicitly about potential problems for each domain that could be expected in the (near) future;
C. Foretelling the most likely dying scenario.
2. A single coaching session for GPs with a physician specialized in palliative care. Each individual coaching session focuses on an identified patient included in the study. In this session the GP receives feedback and suggestions on the proposed proactive palliative care plan, potentional future problems and potential dying scenarios;
3. Two peer group sessions of the participating intervention GPs, eight and ten months after the initial training session. In these sessions the main focus is on patient-GP communication techniques regarding the initiation of transfer to a palliative care trajectory.
The GPs in the control group will be asked to provide usual care. This implies no participation on the training program and no access to the developed tools. Consultation in palliative care will be possible as usual, by telephone contact with a consultant of the palliative care consultation team of the Comprehensive Cancer Center on initiative of the GP him/herself.
|- Primary outcome||1. The number of identified patients who benefit of palliative care;|
2. Place of death;
3. Number of transitions;
4. Out of hours contact.
|- Secondary outcome||GPs satisfaction about delivered palliative care.|
|- Timepoints||From all patients that died during the observational period demographics and disease history (number of contacts with own GP in last month before death, number of contacts with GPs’ out-of-hours organization in last three months before death, number of hospital admissions in last three months before death, place of death) will be extracted from the patients records and collected by the GPs of the intervention and control group. This data collection started at the end of 2010 and will be finished at the end of the first quarter of 2011. From the participating general practitioners information we will collect demographic information, but also information about their practice and their interest in palliative care. We also gather information about the patients in the GPs’ practice that currently receive palliative care (number of them, demographics, frequency of contact with GP, disciplines involved in current care, presence of a analysis of problems and needs in all palliative care domains and presence of a current status document at GPs’ out of hours organization.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. MD. B. Thoonsen|
|- CONTACT for SCIENTIFIC QUERIES||PhD. Y. Engels|
|- Sponsor/Initiator ||University Medical Center St. Radboud|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||According to the WHO, patients who can benefit from palliative care should be identified earlier to enable proactive palliative care. Up to now this hardly has been addressed in scientific literature. Therefore, the aim of our study is to determine if training GPs in how to identify palliative patients in an early phase of their disease trajectory and how to structure palliative care proactively, can improve different aspects of the quality of the remaining life of patients with severe chronic diseases such as COPD, CHF and cancer.|
To achieve this aim we want to answer the following questions:
1. Does early identification and proactive palliative care planning of palliative patients by the GP has an effect on place of death, number of transitions and number of contacts with the out of hours primary care service?
2. How does the combination of early identification and proactive palliative care planning of palliative patients influence self-efficacy of their ability to provide palliative care?
A two armed randomized controlled trial was performed to study the effect of training GPs in early identification of patients in a palliative care trajectory in combination with a structured proactive palliative care approach including a coaching session with a physician specialized in palliative care. The following primary outcome variables will be assessed; the number of identified patients who benefit of palliative care, place of death, number of transitions and out of hours contact.
|- Main changes (audit trail)|
|- RECORD||17-mrt-2011 - 25-mrt-2011|